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FDA Advisory on Use of SimplyThick for Premature Infants

The Rhode Island Department of Health (HEALTH) informs consumers that the FDA has advised parents, caregivers, and healthcare providers to not feed SimplyThick, a thickening agent used for management of swallowing disorders, to infants born before 37 weeks. Use of this product may cause necrotizing enterocolitis (NEC). NEC is a life-threatening condition that can cause inflammation and destruction of an infantís intestinal tissue.

FDA has received reports of infant illness from at least four medical centers throughout the country. As of May 20, FDA has received reports of 15 cases of NEC and two deaths of premature infants who were fed SimplyThick for varying amounts of time. The product was mixed with breast milk or with infant formula.

FDA is investigating the link between SimplyThick and the illness and deaths and will provide updates as more information is available.

Symptoms of NEC can include a bloated abdominal area, feeding intolerance, greenish-tinged vomit and bloody stools. Any parent who has an infant with these symptoms should contact their healthcare provider immediately. Any parent who has questions about the use of this product should contact their healthcare provider.

To check for updates from the FDA, visit http://www.fda.gov

Related links

Department or agency: Department of Health

Online: http://www.health.ri.gov

Release date: 05-23-2011

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